To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01322282
First received: March 23, 2011
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

This study is designed to assess bioequivalence between two products used for treatment of allergy.


Condition Intervention Phase
Allergy
Drug: Cetirizine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Open-Label, Single-Dose, Three-Period Crossover Bioequivalence Study to Compare an Orodispersible Tablet (ODT) Formulation of Cetirizine HCl 10 mg Taken With and Without Water Compared With a Standard Marketed 10 mg Tablet Taken With Water

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Maximum Observed Plasma Concentration [ Time Frame: During 32 hours post-dose ] [ Designated as safety issue: No ]
    Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)

  • Bioavailability [AUC(0-t)] [ Time Frame: During 32 hours post-dose ] [ Designated as safety issue: No ]
    Bioavailability [AUC(0-t)] is a measure of how much of the drug reaches the person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour * nanograms (ng) per milliliter (mL).

  • Bioavailability Extrapolated to Infinity [AUC (0-∞)] [ Time Frame: 32 hours post-dose ] [ Designated as safety issue: No ]
    Bioavailability Extrapolated to Infinity [AUC (0-∞)] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-∞) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-∞).


Secondary Outcome Measures:
  • Time of Maximum Concentration [ Time Frame: During 32 hours post-dose ] [ Designated as safety issue: No ]
    The time at which maximum concentration is reached (Tmax)

  • Terminal Elimination Rate Constant [ Time Frame: During 32 hours post-dose ] [ Designated as safety issue: No ]
    The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose

  • Terminal Phase Plasma Half-Life [ Time Frame: During 32 hours post-dose ] [ Designated as safety issue: No ]
    Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose.

  • Area under the Curve to the Tmax of the Reference Products [ Time Frame: During 32 hours post-dose ] [ Designated as safety issue: No ]
    Area under the plasma concentration versus time curve to the time of the maximum concentration of the reference products (AUCReftmax)

  • Relative percentage of AUCT with respect to AUC∞ (AUCT/∞) [ Time Frame: During 32 hours post-dose ] [ Designated as safety issue: No ]

    AUCT is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration.

    AUC∞ is the area under the plasma concentration versus time curve from start of drug administration until extrapolated infinite time.

    AUCT/ AUC∞ is an inversed measure of how large the extrapolated area under the curve is.


  • Mean Residence Time [ Time Frame: During 32 hours post-dose ] [ Designated as safety issue: No ]
    The average amount of time a particle (e.g., a drug substance molecule) remains in a compartment or system.


Enrollment: 36
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ODT with Water
Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken with 240 mL of water
Drug: Cetirizine
A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits
Other Name: Not yet marketed
Experimental: ODT Without Water
Experimental Cetirizine 10 mg Orodispersible Tablet (ODT) taken without 240 mL of water
Drug: Cetirizine
A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits
Other Name: Not yet marketed
Active Comparator: FCT with Water
Marketed Cetirizine 10 mg Film-Coated Tablet (FCT) taken with 240 mL of water
Drug: Cetirizine
A single 10 mg dose of a marketed Cetirizine Film-Coated Tablet (FCT), with a 7-day washout period between visits
Other Name: Benadryl One A Day 10 mg Film-Coated Tablet

Detailed Description:

This study is designed to evaluate if a test formulation of cetirizine 10 mg orodispersible tablet (ODT) taken with and without water is bioequivalent to a marketed reference formulation of cetirizine 10 mg tablet (Benadryl One A Day, McNeil Products Ltd, UK) taken with water. This study will also evaluate the tolerability of test and reference formulations.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects
  • Volunteers aged of at least 18 years but not older than 55 years
  • Subjects will have a Body Mass Index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2
  • Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study
  • Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
  • Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)
  • Has signed and dated the informed consent document, indicating that the subject has been informed of all pertinent aspects of the study
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Seated pulse rate below 45 bpm or higher than 90 bpm at screening
  • Seated blood pressure below 90/60 mmHg or higher than 140/90 mmHg at screening
  • Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson subsidiaries; and the families of each)
  • Presence of any tongue piercings
  • Presence of braces
  • Females who are pregnant or are lactating
  • Females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
  • Females who are pregnant according to a positive serum pregnancy test
  • Any medical history or condition, or use of any drug or medication, that the investigator determines could compromise subject safety or the evaluation of results.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322282

Locations
Canada, Quebec
Algorithme Pharma Inc.
Mount-Royal, Quebec, Canada, H3P 3P1
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT01322282     History of Changes
Other Study ID Numbers: CETALY1006
Study First Received: March 23, 2011
Last Updated: July 6, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Cetirizine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014